Renal Cell Carcinoma (RCC)Phase 1NCT02837991
A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma
A Phase 1 study testing CDX-014 in people with Renal Cell Carcinoma (RCC) and Clear-cell Renal Cell Carcinoma, run by Celldex Therapeutics at 5 sites in United States.
Trial summary
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma
- What is being tested?
- CDX-014
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2016to 16 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary renal cell carcinoma or histologically confirmed clear cell ovarian carcinoma.
- For RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies. For OCCC, at least one line of prior therapy with a platinum and taxane regimen.
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- Measureable (target) disease.
- Must have available tumor tissue for TIM-1 expression testing
- Life expectancy ≥ 3 months
- If of childbearing potential (male or female), agrees to use effective contraception during study treatment and for at least 6 months following last treatment dose.
Who cannot join
- Prior therapy containing MMAE
- Any prior cytotoxic chemotherapy regimen, including antibody drug conjugates for RCC or cytotoxic chemotherapy within 3 weeks of study treatment for OCCC
- Tyrosine kinase inhibitor (TKI) therapy within 2 weeks or at least 5 half-lives (whichever is longer) prior to planned start of study treatment.
- Monoclonal antibody therapy within 4 weeks prior to the planned start of study treatment.
- Radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
- Major surgery or significant traumatic injury within 4 weeks prior to study entry.
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- Use of other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study treatment.
- Concurrent severe and/or uncontrolled medical conditions (uncontrolled diabetes or infection), known infection with HIV, Hepatitis B or Hepatitis C.
- Brain metastases, unless previously treated and asymptomatic and not progressive for 2 months.
- Significant cardiovascular disease (including congestive heart failure).
- Other malignancy except for treated and cured basal or squamous cell skin cancer, cured in situ cancers, or other cancer from which the patient has been disease-free for ≥ 3 years.
- Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
- Chronic use of systemic corticosteroid above an accepted physiologic dose (5mg per day of prednisone or equivalent) within 7 days of enrollment except when used as premedication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase l Open-Label, Dose Escalation and Cohort Expansion Study, to Assess the Safety and Activity of the Antibody-Drug Conjugate CDX-014 in Advanced or Metastatic Renal Cell Carcinoma (RCC) and Advanced or Metastatic Ovarian Clear Cell Carcinoma (OCCC)
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
Read the detailed description
CDX-014 is an antibody-drug conjugate that binds to a protein called TIM-1, which is found on a high percentage of kidney cells that are clear or papillary and ovarian cancer cells that are clear cell.
The study will enroll patients with advanced or metastatic renal cell carcinoma and ovarian clear cell carcinoma to determine the safety and efficacy of CDX-014.
This study will include a Dose-Escalation Phase followed by a Cohort Expansion Phase
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
- Conditions
- Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Kidney Neoplasms, Metastatic Renal Cell Carcinoma, Ovarian Clear Cell Carcinoma
- Being tested
- CDX-014
- Keywords
- Kidney Cancer, Celldex, Dose Escalation, Ovarian Cancer, Ovarian Carcinoma, Kidney Diseases
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Ovarian Neoplasms, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-014Drug
| Study group | Role | What they receive |
|---|---|---|
| CDX-014 | Experimental | During the treatment phase of the study, patients will receive CDX-014 treatment every 3 weeks (RCC or OCCC) or every 2 weeks (RCC) as long as they remain eligible. Patients may be discontinued from CDX-014 treatment based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.
The planned dose of CDX-014 depends on the cohort assigned at enrollment. Receives: Drug: CDX-014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation - Determine Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of CDX-014 (in mg/kg). MTD will be defined as the highest dose-level where DLT (dose-limiting toxicity) occurs in less than 33% of treated patients.
Measured: Within 21 days after first dose.
Cohort Expansion - Assess Objective Response Rate (ORR)
Objective Response Rate (ORR) defined as the proportion of patients who achieve radiographic partial or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
Measured: Evaluated every 6-9 weeks following treatment initiation until treatment is discontinued or disease progression, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Why it stopped: Development of CDX-014 discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837991
- Sponsor's protocol ID
- CDX014-01
- Status last verified
- Nov 2018
- First submitted
- 13 Jul 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
McGregor BA, Gordon M, Flippot R, Agarwal N, George S, Quinn DI, Rogalski M, Hawthorne T, Keler T, Choueiri TK. Safety and efficacy of CDX-014, an antibody-drug conjugate directed against T cell immunoglobulin mucin-1 in advanced renal cell carcinoma. Invest New Drugs. 2020 Dec;38(6):1807-1814. doi: 10.1007/s10637-020-00945-y. Epub 2020 May 29.
PubMed 32472319
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase l Open-Label, Dose Escalation and Cohort Expansion Study, to Assess the Safety and Activity of the Antibody-Drug Conjugate CDX-014 in Advanced or Metastatic Renal Cell Carcinoma (RCC) and Advanced or Metastatic Ovarian Clear Cell Carcinoma (OCCC)
- ClinicalTrials.gov ID
- NCT02837991
- Acronym / sponsor ID
- CDX014-01
- Conditions
- Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Kidney Neoplasms, Metastatic Renal Cell Carcinoma, Ovarian Clear Cell Carcinoma
- Keywords
- Kidney Cancer, Celldex, Dose Escalation, Ovarian Cancer, Ovarian Carcinoma, Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of CDX-014 discontinued
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
Detailed description
CDX-014 is an antibody-drug conjugate that binds to a protein called TIM-1, which is found on a high percentage of kidney cells that are clear or papillary and ovarian cancer cells that are clear cell.
The study will enroll patients with advanced or metastatic renal cell carcinoma and ovarian clear cell carcinoma to determine the safety and efficacy of CDX-014.
This study will include a Dose-Escalation Phase followed by a Cohort Expansion Phase
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDX-014 | Experimental | Drug: CDX-014During the treatment phase of the study, patients will receive CDX-014 treatment every 3 weeks (RCC or OCCC) or every 2 weeks (RCC) as long as they remain eligible. Patients may be discontinued from CDX-014 treatment based on the results of disease assessments or if experiencing side effects that make study therapy intolerable. The planned dose of CDX-014 depends on the cohort assigned at enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary renal cell carcinoma or histologically confirmed clear cell ovarian carcinoma.
- For RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies. For OCCC, at least one line of prior therapy with a platinum and taxane regimen.
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- Measureable (target) disease.
- Must have available tumor tissue for TIM-1 expression testing
Key exclusion criteria (13 listed)
- Prior therapy containing MMAE
- Any prior cytotoxic chemotherapy regimen, including antibody drug conjugates for RCC or cytotoxic chemotherapy within 3 weeks of study treatment for OCCC
- Tyrosine kinase inhibitor (TKI) therapy within 2 weeks or at least 5 half-lives (whichever is longer) prior to planned start of study treatment.
- Monoclonal antibody therapy within 4 weeks prior to the planned start of study treatment.
- Radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDX-014 | Drug | CDX-014 |
Primary outcome
Dose Escalation - Determine Maximum Tolerated Dose (MTD)
Time frame: Within 21 days after first dose.
Determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of CDX-014 (in mg/kg). MTD will be defined as the highest dose-level where DLT (dose-limiting toxicity) occurs in less than 33% of treated patients.
Cohort Expansion - Assess Objective Response Rate (ORR)
Time frame: Evaluated every 6-9 weeks following treatment initiation until treatment is discontinued or disease progression, up to 5 years.
Objective Response Rate (ORR) defined as the proportion of patients who achieve radiographic partial or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
Results and safety
The study was stopped early (reason given: Development of CDX-014 discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Results publication: PubMed 32472319McGregor BA, Gordon M, Flippot R, Agarwal N, George S, Quinn DI, Rogalski M, Hawthorne T, Keler T, Choueiri TK. Safety and efficacy of CDX-014, an antibody-drug conjugate directed against T cell immunoglobulin mucin-1 in advanced renal cell carcinoma. Invest New Drugs. 2020 Dec;38(6):1807-1814. doi: 10.1007/s10637-020-00945-y. Epub 2020 May 29.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDX-014 in people with Renal Cell Carcinoma (RCC) and Clear-cell Renal Cell Carcinoma, run by Celldex Therapeutics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Development of CDX-014 discontinued). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation - Determine Maximum Tolerated Dose (MTD) (time frame: Within 21 days after first dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.